Keeping the Label out of the Case

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Virtually all physicians prescribe drugs and medical devices for off-label uses. The pace of FDA approval of new drugs and devices (or of new indications for existing drugs) necessarily lags behind the pace of medical research. Physicians will therefore always be aware of a recent study showing that a drug offers hope to a patient long before the drug’s manufacturer completes a clinical trial and asks the FDA to approve the drug when labeled for that new use.

The FDA acknowledges this reality: It does not purport to regulate the practice of medicine.

Medical malpractice law acknowledges this reality: The “standard of care” is the standard of care, not the status of a drug’s package insert. A physician commits malpractice if he or she falls beneath the standard of care; a physician does not commit malpractice by prescribing a drug off-label for an accepted medical use.

Here’s our question: If labeled indications do not limit the uses for which a physician can prescribe a drug, why is a drug’s package insert admissible evidence in a malpractice case involving routine off-label use?

Don’t get us wrong: If a drug is contraindicated for a certain use and the physician overlooks or ignores the contraindication, that fact may well be relevant in a malpractice case; the insert would be admissible. And there may be other situations where information contained on the drug’s labeling informs the decision whether the physician met the standard of care.

But we’re thinking about routine off-label use. The drug is labeled for use in treating one type of cancer. Studies published in peer-reviewed medical literature suggest that the drug may be useful as part of a drug cocktail to treat a different type of cancer. The physician prescribes the drug for that off-label use. The package insert is silent about that use — no contraindication, no warning, no precaution, no nothing.

In that situation, why should the package insert be admissible evidence in a malpractice case brought against the physician? The insert says nothing about the standard of care. It says nothing about the propriety of prescribing the drug for the off-label use. And there’s at least a chance that jurors will be confused by the FDA’s approval of a drug for one purpose and believe that prescribing a drug for an off-label use is somehow improper.

We’re products lawyers, not med mal lawyers, so don’t expect us to beat this idea to a pulp. But it seems to us the argument is worth pursuing. Shouldn’t physicians regularly be asserting that, in cases of routine off-label prescribing, the rules of evidence should keep the label out of the case?see original